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Asia: Medical Device Regulatory Issues

Regulations for medical devices vary by country in Asia and are always changing. India and Malaysia, which previously did not have regulations for product registration, have recently adopted stricter and more comprehensive guidelines. In Taiwan, where registration rules were different for domestic and foreign products, the process has now been made fairer for foreign companies. The gradual adoption of international standards is taking place in Thailand, where only local standards previously applied. Countries with inadequate or unclear laws, like China, have set up new governing bodies for devices and drugs. Japan also revised its policies. Korea, however, has done little to implement promised reforms. These issues are discussed, with analyses of medical device markets, key regulatory issues, medical device registration requirements, and explanations of national regulatory bodies. Countries include China, Japan, South Korea, Taiwan, and Malaysia.